PEG3350 vs Senna for Constipation
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial compares the effectiveness of PEG3350 (a laxative) and senna (a natural laxative) in easing constipation after urogynecologic surgery. It examines how many patients develop obstructed defecation syndrome (a type of constipation) with each treatment in the week following surgery. Women undergoing surgery for pelvic organ prolapse or stress urinary incontinence are suitable candidates for this study. Participants will take the assigned medication for seven days, complete a questionnaire before and after surgery, and maintain a daily bowel diary. As a Phase 4 trial, this research aims to understand how these FDA-approved treatments can benefit more patients.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What is the safety track record for these treatments?
Research has shown that both polyethylene glycol 3350 (PEG3350) and senna are generally safe and effective for treating constipation. The FDA has approved PEG3350 as a laxative for adults with constipation, and it is available without a prescription. Studies indicate it remains safe even with long-term use. Most people do not experience serious side effects, but it is not recommended for individuals with certain conditions, such as a blocked bowel.
Senna, another FDA-approved laxative, is also available over-the-counter. It is typically safe for most adults when used for up to one week. Some individuals might experience mild side effects like stomach cramps or diarrhea, particularly those with irritable bowel syndrome (IBS).
Both treatments are widely used and considered safe for short-term relief of constipation.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about these treatments for constipation because they offer distinct approaches to relieving the condition. Senna, a natural plant extract, acts as a stimulant laxative by triggering muscle contractions in the intestines, potentially providing faster relief. On the other hand, Polyethylene Glycol 3350, commonly known as PEG3350, is an osmotic laxative that works by drawing water into the bowel, which can soften stools and make them easier to pass. This dual approach allows for more personalized treatment options, catering to different patient needs and potentially improving overall efficacy and comfort compared to existing standard treatments like fiber supplements or over-the-counter laxatives.
What evidence suggests that this trial's treatments could be effective for postoperative constipation?
This trial will compare the effectiveness of polyethylene glycol 3350 (PEG3350) and senna for treating constipation. Studies have shown that PEG3350 effectively treats constipation, with research indicating that taking 17 grams daily can improve bowel movements and provide significant relief for those with occasional or chronic constipation. In this trial, some participants will receive PEG3350, while others will receive senna. Senna has also proven effective by stimulating the bowel to ease constipation, often offering relief similar to PEG3350. Both treatments have been shown to increase bowel movement frequency and improve the quality of life for those dealing with constipation. These findings support using either PEG3350 or senna to address constipation issues.678910
Who Is on the Research Team?
Keila S Muniz, MD
Principal Investigator
St. Joseph's Health
Are You a Good Fit for This Trial?
This trial is for individuals experiencing constipation after urogynecologic surgery. Participants will take a daily medication for seven days post-surgery and keep track of their bowel movements. They must be willing to fill out questionnaires before and after the treatment period.Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either PEG3350 or Senna for 7 days after urogynecologic surgery
Follow-up
Participants are monitored for safety and effectiveness after treatment, including completion of a bowel diary and ODS questionnaire
What Are the Treatments Tested in This Trial?
Interventions
- Polyethylene glycol 3350
- Senna
Find a Clinic Near You
Who Is Running the Clinical Trial?
St. Joseph's Health, New York
Lead Sponsor